AbbVie Receives Positive CHMP Opinion for Upadacitinib (RINVOQ®) for the Treatment of Adults and Adolescents with Non-segmental Vitiligo

Rhea-AI Summary

AbbVie (NYSE: ABBV) received a positive CHMP opinion recommending approval of upadacitinib (RINVOQ 15 mg, once daily) for adults and adolescents with non-segmental vitiligo in the EU. If approved, it is expected to become the first systemic treatment for this chronic autoimmune skin disease.

The opinion is based on Phase 3 Viti-Up studies, where upadacitinib met co-primary endpoints (T-VASI 50, F-VASI 75) at week 48, with a safety profile consistent with approved uses.

Positive

• Positive CHMP opinion recommending EU approval of upadacitinib for non-segmental vitiligo
• Potential first systemic treatment option for adults and adolescents with non-segmental vitiligo
• Phase 3 Viti-Up studies met both co-primary repigmentation endpoints at week 48
• Safety profile consistent with existing approved indications, with no new safety signals reported

Negative

• European Commission final decision is still pending, creating regulatory timing uncertainty
• Use of upadacitinib in non-segmental vitiligo is not currently approved in the EU

News Market Reaction – ABBV

+0.38%

+0.38% Session close to close

In the Jun 29 session, ABBV gained 0.38%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlights a positive CHMP opinion for RINVOQ in non-segmental vitiligo, supported...

Analysis

This announcement highlights a positive CHMP opinion for RINVOQ in non-segmental vitiligo, supported by Phase 3 Viti-Up data achieving T-VASI 50 and F-VASI 75 at 48 weeks. Investors may watch for the final European Commission decision and longer-term safety outcomes.

Key Figures

T-VASI 50 endpoint: ≥50% improvement in total body repigmentation F-VASI 75 endpoint: ≥75% improvement in facial repigmentation Dose: 15 mg once daily +1 more

4 metrics

T-VASI 50 endpoint ≥50% improvement in total body repigmentation Co-primary endpoint achieved at week 48 in Phase 3 Viti-Up

F-VASI 75 endpoint ≥75% improvement in facial repigmentation Co-primary endpoint achieved at week 48 in Phase 3 Viti-Up

Dose 15 mg once daily Upadacitinib regimen evaluated for non-segmental vitiligo in EU submission

Assessment timepoint Week 48 Timing for total body and facial repigmentation endpoints

Historical Context

5 past events · Latest: Jun 24 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Jun 24	Brand initiative	Positive	+0.1%	BOTOX Cosmetic announced 2026 Confidence Collective entrepreneurial grant cohort.
Jun 23	Regulatory approval	Positive	+2.1%	Boey received Health Canada approval for rapid-onset aesthetic neurotoxin.
Jun 23	EU drug approval	Positive	+2.1%	MAVIRET gained EU approval for treating acute HCV infection.
Jun 23	EU label expansion	Positive	+2.1%	SKYRIZI approved in EU for pediatric moderate to severe plaque psoriasis.
Jun 22	Acquisition deal	Positive	+6.6%	Agreement to acquire Apogee Therapeutics, expanding late-stage immunology assets.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

ABBV shares have recently shown positive alignment between favorable regulatory/portfolio news and same-day price gains.

Key Terms

chmp, phase 3, randomized, placebo-controlled, +2 more

6 terms

chmp regulatory

"the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted"

The CHMP is the European Medicines Agency’s expert panel that evaluates whether a medicine for people should be recommended for approval across the EU. Think of it as a technical review board whose positive or negative opinion strongly affects a drug maker’s ability to sell a product in the European market, shaping potential revenues, regulatory risk and investment timelines for companies developing or marketing therapies.

phase 3 medical

"Positive CHMP opinion is supported by data from the Phase 3 Viti-Up clinical studies"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

randomized medical

"two replicate, randomized, placebo-controlled, double-blind studies evaluating the efficacy"

Randomized means participants or units in a study are assigned to different groups by chance rather than by choice, like flipping a coin to decide who gets a new treatment and who gets a comparison. For investors, randomized designs matter because they reduce bias and make results more trustworthy, so outcomes from randomized studies carry more weight when assessing regulatory approval, commercial prospects, and the risk that trial results will change a company’s valuation.

placebo-controlled medical

"two replicate, randomized, placebo-controlled, double-blind studies evaluating the efficacy"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

double-blind medical

"two replicate, randomized, placebo-controlled, double-blind studies evaluating the efficacy"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

co-primary endpoints medical

"upadacitinib 15 mg met both co-primary endpoints and key secondary endpoints"

Co-primary endpoints are two or more key outcomes that a clinical study must meet simultaneously to be considered successful, like needing both improved symptoms and a marker of disease reduction. For investors, they matter because meeting multiple agreed goals strengthens the evidence that a treatment works and can influence regulatory approval, market access and commercial potential—similar to a product needing to pass both safety and performance checks before launch.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

• If approved, upadacitinib is expected to be the first systemic medication for patients with non-segmental vitiligo, addressing important treatment needs for those living with the chronic, unpredictable autoimmune disease
• Positive CHMP opinion is supported by data from the Phase 3 Viti-Up clinical studies, in which upadacitinib achieved both co-primary endpoints demonstrating at least a 50% improvement in total body repigmentation (T-VASI 50) and at least a 75% improvement in facial repigmentation (F-VASI 75) from baseline at week 48¹

NORTH CHICAGO, Ill., June 29, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of upadacitinib (RINVOQ^®; 15 mg, once daily) for the treatment of adult and adolescent patients with non-segmental vitiligo (NSV). The final European Commission decision is expected in the coming months. If approved, upadacitinib is expected to be the first systemic medication for patients with non-segmental vitiligo.

"Vitiligo is an autoimmune skin disease with high stigma and significant burden to patients with limited treatment options available," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "A positive opinion for upadacitinib in non-segmental vitiligo is an important step forward in providing patients with a systemic treatment option."

The CHMP positive opinion is supported by data from the ongoing Phase 3 Viti-Up clinical program, including two replicate, randomized, placebo-controlled, double-blind studies evaluating the efficacy and safety of upadacitinib in adult and adolescent patients with NSV. Upadacitinib 15 mg met both co-primary endpoints and key secondary endpoints, with significant improvements in total body and facial repigmentation.¹ The safety profile of upadacitinib 15 mg was consistent with that observed in approved indications, with no new safety signals.¹

Upadacitinib is approved in the European Union (EU) for the treatment of adults and adolescents with atopic dermatitis, and adults with radiographic axial spondylarthritis, non-radiographic axial spondylarthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, Crohn's disease, and giant cell arteritis. Use of upadacitinib in NSV is not currently approved in the EU.

About Vitiligo
Vitiligo is a chronic, autoimmune disease characterized by the loss of pigment-producing cells (melanocytes), resulting in white patches of skin that can appear anywhere on the body and at any time.² It imposes a significant psychosocial burden, profoundly affecting an individual's confidence, identity and daily life.³ Non-segmental vitiligo (NSV), the most common form of vitiligo afflicting approximately 84% of patients, is marked by symmetrical and bilateral depigmented white patches and is prone to unpredictable progression even after long periods of stability.^2,4-6 While location varies, many patients report patches on critical areas such as the face, feet, hands and groin. Despite its immune-mediated nature, vitiligo is often considered primarily a cosmetic problem, which can lead to stigma and psychological impact on patients' lives.^7-9 Vitiligo management is anchored in three primary treatment goals: disease stabilization, repigmentation, and maintaining repigmentation.^10,11 There are currently no approved systemic medicines specifically indicated for these treatment goals in vitiligo.

About Viti-Up Clinical Trials
Upadacitinib M19-044 was conducted under a single protocol encompassing two replicate Phase 3 studies (Study 1 and Study 2) with independent randomization, investigative sites, data collection, analysis and reporting for each study. The trials were designed to evaluate the efficacy, safety and tolerability of upadacitinib in adult and adolescent patients (ages 12 and older) living with non-segmental vitiligo (NSV) who were eligible for systemic therapy. In Period A of both studies, participants were randomized in a 2:1 ratio to receive either upadacitinib 15 mg once daily or placebo for 48 weeks. Participants who completed Period A were eligible to enter Period B, a 112-week open-label extension in which all patients received upadacitinib 15 mg once daily. In total, Study 1 and Study 2 Periods A and B span 160 weeks. The two trials randomized 614 participants with NSV across 90 sites worldwide. More information on these trials can be found at www.clinicaltrials.gov (NCT06118411).

The co-primary endpoints were based on the achievement of Total Vitiligo Area Scoring Index (T-VASI) 50, defined as at least 50% reduction in T-VASI from baseline, at week 48, and the achievement of Facial Vitiligo Area Scoring Index (F-VASI) 75, defined as at least 75% reduction in F-VASI from baseline, at week 48 with the treatment of upadacitinib 15 mg compared with placebo in adults and adolescents with NSV.

The secondary endpoints include the achievement of F-VASI 50, defined as at least a 50% reduction in F-VASI from baseline, at week 48, and the achievement of F-VASI 75, defined as at least a 75% reduction in facial vitiligo area from baseline, at week 24. These endpoints were designed to assess the degree and timing of re-pigmentation on the face, an area among the most visible and psychosocially impactful for people living with NSV.

About RINVOQ^® (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3, and TYK-2. The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known.

Upadacitinib (RINVOQ) is being studied in Phase 3 clinical trials for alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo. The use of upadacitinib in non-segmental vitiligo is not approved; its safety and efficacy are under regulatory review by the U.S. FDA and the European Medicines Agency.

EU Indications and Important Safety Information about RINVOQ^® (upadacitinib)¹²

Indications

Rheumatoid arthritis

RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with methotrexate.

Psoriatic arthritis

RINVOQ is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate.

Axial spondyloarthritis

Non-radiographic axial spondyloarthritis (nr-axSpA)

RINVOQ is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).

Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)

RINVOQ is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.

Giant cell arteritis

RINVOQ is indicated for the treatment of giant cell arteritis (GCA) in adult patients.

Atopic dermatitis

RINVOQ is indicated for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents 12 years and older who are candidates for systemic therapy.

Ulcerative colitis

RINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

Crohn's disease

RINVOQ is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

Important Safety Information

Contraindications
RINVOQ is contraindicated in patients hypersensitive to the active substance or to any of the excipients, in patients with active tuberculosis (TB) or active serious infections, in patients with severe hepatic impairment, and during pregnancy.

Special warnings and precautions for use
RINVOQ should only be used if no suitable treatment alternatives are available in patients:
- 65 years of age and older;
 - patients with history of atherosclerotic cardiovascular (CV) disease or other CV risk factors (such as current or past long-time smokers);
 - patients with malignancy risk factors (e.g. current malignancy or history of malignancy)

Use in patients 65 years of age and older
Considering the increased risk of MACE, malignancies, serious infections, and all-cause mortality in patients ≥65 years of age, as observed in a large randomised study of tofacitinib (another Janus Kinase (JAK) inhibitor), RINVOQ should only be used in these patients if no suitable treatment alternatives are available. In patients ≥65 years of age, there is an increased risk of adverse reactions with RINVOQ 30 mg once daily. Consequently, the recommended dose for long-term use in this patient population is 15 mg once daily.

Immunosuppressive medicinal products
Use in combination with other potent immunosuppressants is not recommended.

Serious infections
Serious and sometimes fatal infections have been reported in patients receiving RINVOQ. The most frequent serious infections reported included pneumonia and cellulitis. Cases of bacterial meningitis and sepsis have been reported with RINVOQ. Among opportunistic infections, TB, multidermatomal herpes zoster, oral/esophageal candidiasis, and cryptococcosis have been reported. RINVOQ should not be initiated in patients with an active, serious infection, including localized infections. RINVOQ should be interrupted if a patient develops a serious or opportunistic infection until the infection is controlled. A higher rate of serious infections was observed with RINVOQ 30 mg compared to 15 mg. As there is a higher incidence of infections in the elderly and patients with diabetes in general, caution should be used when treating these populations. In patients ≥65 years of age, RINVOQ should only be used if no suitable treatment alternatives are available.

Tuberculosis
Patients should be screened for TB before starting RINVOQ. RINVOQ should not be given to patients with active TB. Anti-TB therapy may be appropriate for select patients in consultation with a physician with expertise in the treatment of TB. Patients should be monitored for the development of signs and symptoms of TB.

Viral reactivation
Viral reactivation, including cases of herpes zoster, was reported in clinical studies. The risk of herpes zoster appears to be higher in Japanese patients treated with RINVOQ. Consider interruption of RINVOQ if the patient develops herpes zoster until the episode resolves. Screening for viral hepatitis and monitoring for reactivation should occur before and during therapy. If hepatitis B virus DNA is detected, a liver specialist should be consulted.

Vaccination
The use of live, attenuated vaccines during or immediately prior to therapy is not recommended. It is recommended that patients be brought up to date with all immunizations, including prophylactic zoster vaccinations, prior to initiating RINVOQ, in agreement with current immunization guidelines.

Malignancy
Lymphoma and other malignancies have been reported in patients receiving JAK inhibitors, including RINVOQ. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a higher rate of malignancies, particularly lung cancer, lymphoma, and non-melanoma skin cancer (NMSC), was observed with tofacitinib compared to tumour necrosis factor (TNF) inhibitors. A higher rate of malignancies, including NMSC, was observed with RINVOQ 30 mg compared to 15 mg. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. In patients ≥65 years of age, patients who are current or past long-time smokers, or patients with other malignancy risk factors (e.g., current malignancy or history of malignancy), RINVOQ should only be used if no suitable treatment alternatives are available.

Hematological abnormalities
Treatment should not be initiated, or should be temporarily interrupted, in patients with hematological abnormalities observed during routine patient management.

Gastrointestinal perforations
Events of diverticulitis and gastrointestinal perforations have been reported in clinical trials and from post-marketing sources. RINVOQ should be used with caution in patients who may be at risk for gastrointestinal perforation (e.g., patients with diverticular disease, a history of diverticulitis, or who are taking non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or opioids. Patients with active Crohn's disease are at increased risk for developing intestinal perforation. Patients presenting with new onset abdominal signs and symptoms should be evaluated promptly for early identification of diverticulitis or gastrointestinal perforation.

Major adverse cardiovascular events
MACE were observed in clinical studies of RINVOQ. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a higher rate of MACE, defined as CV death, non-fatal myocardial infarction and non-fatal stroke, was observed with tofacitinib compared to TNF inhibitors. Therefore, in patients ≥65 years of age, patients who are current or past long-time smokers, and patients with history of atherosclerotic CV disease or other CV risk factors, RINVOQ should only be used if no suitable treatment alternatives are available.

Lipids
RINVOQ treatment was associated with dose-dependent increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol.

Hepatic transaminase elevations
Treatment with RINVOQ was associated with an increased incidence of liver enzyme elevation. Hepatic transaminases must be evaluated at baseline and thereafter according to routine patient management. If alanine transaminase (ALT) or aspartate transaminase (AST) increases are observed and drug-induced liver injury is suspected, RINVOQ should be interrupted until this diagnosis is excluded.

Venous thromboembolism
Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) were observed in clinical trials for RINVOQ. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a dose‑dependent higher rate of VTE including DVT and PE was observed with tofacitinib compared to TNF inhibitors. In patients with CV or malignancy risk factors, RINVOQ should only be used if no suitable treatment alternatives are available. In patients with known VTE risk factors other than CV or malignancy risk factors (e.g. previous VTE, patients undergoing major surgery, immobilisation, use of combined hormonal contraceptives or hormone replacement therapy, and inherited coagulation disorder), RINVOQ should be used with caution. Patients should be re-evaluated periodically to assess for changes in VTE risk. Promptly evaluate patients with signs and symptoms of VTE and discontinue RINVOQ in patients with suspected VTE.

Retinal vein occlusion
Retinal vein occlusion has been reported in patients treated with JAK inhibitors, including upadacitinib. Patients should be advised to promptly seek medical care in case they experience symptoms suggestive of retinal vein occlusion.

Hypersensitivity reactions
Serious hypersensitivity reactions such as anaphylaxis and angioedema have been reported in patients receiving RINVOQ. If a clinically significant hypersensitivity reaction occurs, discontinue RINVOQ and institute appropriate therapy.

Hypoglycemia in patients treated for diabetes
There have been reports of hypoglycemia following initiation of JAK inhibitors, including RINVOQ, in patients receiving medication for diabetes. Dose adjustment of anti-diabetic medication may be necessary in the event that hypoglycemia occurs.

Medication Residue in Stool
Reports of medication residue in stool or ostomy output have occurred in patients taking RINVOQ. Most reports described anatomic (e.g., ileostomy, colostomy, intestinal resection) or functional gastrointestinal conditions with shortened gastrointestinal transit times. Patients should be instructed to contact their healthcare professional if medication residue is observed repeatedly. Patients should be clinically monitored, and alternative treatment should be considered if there is an inadequate therapeutic response.

Giant Cell Arteritis
RINVOQ monotherapy should not be used for the treatment of acute relapses as efficacy in this setting has not been established. Corticosteroids should be given according to medical judgement and practice guidelines.

Adverse reactions
The most commonly reported adverse reactions in RA, PsA, and axSpA clinical trials (≥2% of patients in at least one of the indications) with RINVOQ 15 mg were upper respiratory tract infections, blood creatine phosphokinase (CPK) increased, ALT increased, bronchitis, nausea, neutropenia, cough, AST increased, and hypercholesterolemia. Overall, the safety profile observed in patients with psoriatic arthritis or active axial spondyloarthritis treated with RINVOQ 15 mg was consistent with the safety profile observed in patients with RA.

The most commonly reported adverse reactions in AD trials (≥2% of patients) with RINVOQ 15 mg or 30 mg were upper respiratory tract infection, acne, herpes simplex, headache, blood CPK increased, cough, folliculitis, abdominal pain, nausea, neutropenia, pyrexia, and influenza. Dose dependent increased risks of infection and herpes zoster were observed with RINVOQ. The safety profile for RINVOQ 15 mg and 30 mg in adolescents was similar to that in adults. With long-term exposure, skin papilloma was reported in adolescents in the RINVOQ 15 mg and 30 mg groups.

The most commonly reported adverse reactions in the UC and CD trials (≥3% of patients) with RINVOQ 45 mg, 30 mg or 15 mg were upper respiratory tract infection, pyrexia, blood CPK increased, anemia, headache, acne, herpes zoster, neutropenia, rash, pneumonia, hypercholesterolemia, bronchitis, AST increased, fatigue, folliculitis, ALT increased, herpes simplex, and influenza. The overall safety profile observed in patients with UC was generally consistent with that observed in patients with RA. Overall, the safety profile observed in patients with CD treated with RINVOQ was consistent with the known safety profile for RINVOQ.

Overall, the safety profile observed in patients with GCA treated with RINVOQ 15 mg was generally consistent with the known safety profile for RINVOQ.

The most common serious adverse reactions were serious infections.

The safety profile of RINVOQ with long-term treatment was generally similar to the safety profile during the placebo-controlled period across indications.

This is not a complete summary of all safety information.

See RINVOQ full Summary of Product Characteristics (SmPC) at www.ema.europa.eu

Globally, prescribing information varies; refer to the individual country product label for complete information.

About AbbVie in Immunology
AbbVie is relentless in our pursuit to redefine the standard of care for patients living with immune-mediated conditions, with the goal of helping them live a life free from the limitations of their disease. For more than 20 years, AbbVie has led and helped shape the field of immunology through groundbreaking science and trusted medicines. Building on deep expertise across gastroenterology, rheumatology and dermatology, and other areas of high unmet need, we continue to invest in a broad and differentiated pipeline – spanning innovative modalities, novel mechanisms of actions and next-generation approaches designed to conquer the complex biology underlying immune-mediated disease.

Today, more than 1 million patients worldwide are treated with AbbVie's immunology medicines, approved in more than 175 countries across 19 immune-mediated diseases that impact adult and pediatric populations. As we work to strengthen our legacy and drive the next wave of innovation, we remain focused on delivering meaningful progress for patients and expanding access to our medicines. For more information, please visit www.abbvie.com/immunology.

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Forward-Looking Statements

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

References

1. AbbVie. Data on file ABVRRTI82545
2. Ezzedine K, Eleftheriadou V, Whitton M, van Geel N. Vitiligo. Lancet. 2015;386(9988):74-84. doi:10.1016/S0140-6736(14)60763-7
3. Krüger C, Schallreuter KU. A review of the worldwide prevalence of vitiligo in children/adolescents and adults. Int J Dermatol. 2012;51(10):1206-1212. doi:10.1111/j.1365-4632.2011.05377.x
4. Mazzei Weiss ME. Vitiligo: to biopsy or not to biopsy?. Cutis. 2020;105(4):189-190.
5. Ezzedine K, Lim HW, Suzuki T, et al. Revised classification/nomenclature of vitiligo and related issues: the Vitiligo Global Issues Consensus Conference. Pigment Cell Melanoma Res. 2012;25(3):E1-13
6. Taneja N, Sreenivas V, Sahni K, Gupta V, Ramam M. Disease Stability in Segmental and Non-Segmental Vitiligo. Indian Dermatol Online J. 2021 Aug 2;13(1):60-63. doi: 10.4103/idoj.IDOJ_154_21. PMID: 35198469; PMCID: PMC8809159
7. Hlača N, Žagar T, Kaštelan M, Brajac l, Prpić-Massari L. Current concepts of vitiligo immunopathogenesis. Biomedicines. 2022;10(7):1639. doi:10.3390/biomedicines10071639
8. Abdel-Malek ZA, Jordan C, Ho T, Upadhyay PR, Fleischer A, Hamzavi l. The enigma and challenges of vitiligo pathophysiology and treatment. Pigment Cell Melanoma Res. 2020;33(6):778-787. doi:10.1111/pcmr.12878
9. Birlea SA, Goldstein NB, Norris DA. Repigmentation through melanocyte regeneration in vitiligo. Dermatol Clin. 2017;35(2):205-218. doi:10.1016/j.det.2016.11.015
10. van Geel N, Speeckaert R, Taïeb A, et al. Worldwide expert recommendations for the diagnosis and management of vitiligo: position statement from the International Vitiligo Task Force part 1: towards a new management algorithm. J Eur Acad Dermatol Venereol. 2023;37(11):2173-2184. doi:10.1111/jdv.19451
11. Seneschal J, Boniface K. Vitiligo: Current therapies and future treatments. Dermatol Pract Concept. 2023;13(4S2):e2023313S. doi:10.5826/dpc.1304S2a313
12. RINVOQ [Package Insert]. North Chicago, IL: AbbVie Inc.; 2026

Media:                                         Mary Byun mary.byun@abbvie.com

Investors: Liz Shea liz.shea@abbvie.com

View original content:https://www.prnewswire.com/news-releases/abbvie-receives-positive-chmp-opinion-for-upadacitinib-rinvoq-for-the-treatment-of-adults-and-adolescents-with-non-segmental-vitiligo-302812429.html

SOURCE AbbVie

FAQ

What did AbbVie (NYSE: ABBV) announce on June 29, 2026 about RINVOQ and vitiligo?

AbbVie announced a positive CHMP opinion for upadacitinib (RINVOQ) to treat adults and adolescents with non-segmental vitiligo. According to AbbVie, the opinion recommends EU approval and is based on Phase 3 Viti-Up data showing clinically meaningful repigmentation and a consistent safety profile.

How effective was RINVOQ in the Phase 3 Viti-Up studies for non-segmental vitiligo?

RINVOQ met both co-primary endpoints in the Phase 3 Viti-Up studies for non-segmental vitiligo. According to AbbVie, 15 mg once daily achieved at least 50% total body repigmentation (T-VASI 50) and 75% facial repigmentation (F-VASI 75) from baseline at week 48.

What makes the potential EU approval of RINVOQ for vitiligo significant for ABBV shareholders?

The potential EU approval would add a new indication for RINVOQ in non-segmental vitiligo. According to AbbVie, RINVOQ could become the first systemic medication for this condition, potentially expanding its autoimmune portfolio and reinforcing its dermatology franchise if approval is granted.

Is upadacitinib (RINVOQ) already approved in the EU for other indications besides vitiligo?

Yes, upadacitinib is already approved in the EU for several inflammatory conditions. According to AbbVie, it is approved for atopic dermatitis, multiple axial spondylarthritis forms, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, Crohn's disease and giant cell arteritis, but not yet for non-segmental vitiligo.

What are the next regulatory steps for RINVOQ in non-segmental vitiligo after the CHMP opinion?

Following the positive CHMP opinion, a final decision from the European Commission is expected in the coming months. According to AbbVie, the CHMP recommendation supports approval, but use of upadacitinib in non-segmental vitiligo remains unapproved in the EU until that decision.

What safety profile did RINVOQ show in vitiligo patients in the Phase 3 Viti-Up program?

RINVOQ 15 mg showed a safety profile consistent with its existing approved indications in the Viti-Up program. According to AbbVie, no new safety signals were identified in adult and adolescent patients with non-segmental vitiligo during these ongoing Phase 3 studies.